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New treatment option for Opioid Withdrawal (Disorder)
Official title Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms
ClinicalTrials.gov ID: NCT07079215
What this study is testing
- What it's testing
- This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- Participants aged 19 to 80 years
- Participants currently dependent on opioids, whether prescribed or non-prescribed
- Participants who meet the criteria for opioid use disorder (OUD) according to DSM-5
- Participants with a Clinical Opiate Withdrawal Scale (COWS) score of 5 or higher
- Participants with a Numeric Rating Scale (NRS) pain score of less than 6
You likely can't join if
- Participants with any current uncontrolled or clinically significant medical condition
- Participants with a history of seizures or epilepsy
- Participants with a history of neurological disorders or traumatic brain injury
- Participants who have used long-acting opioids, such as methadone or buprenorphine, continuously for more than 5 days prior to screening
- Participants who have used methadone within 30 days prior to screening
- Participants who have used buprenorphine within 7 days prior to screening
See the full eligibility criteria
- Participants aged 19 to 80 years
- Participants currently dependent on opioids, whether prescribed or non-prescribed
- Participants who meet the criteria for opioid use disorder (OUD) according to DSM-5
- Participants with a Clinical Opiate Withdrawal Scale (COWS) score of 5 or higher
- Participants with a Numeric Rating Scale (NRS) pain score of less than 6
- Participants who have voluntarily decided to participate in the study and have provided written informed consent
- Participants who are willing to comply with the study protocol
- Participants with any current uncontrolled or clinically significant medical condition
- Participants with a history of seizures or epilepsy
- Participants with a history of neurological disorders or traumatic brain injury
- Participants who have used long-acting opioids, such as methadone or buprenorphine, continuously for more than 5 days prior to screening
- Participants who have used methadone within 30 days prior to screening
- Participants who have used buprenorphine within 7 days prior to screening
- Participants with physiological dependence on alcohol or drugs other than opioids, tobacco, or marijuana
- Participants diagnosed with a major psychiatric disorder (psychosis, schizophrenia, or bipolar disorder)
- Participants who are currently hospitalized due to a recent suicide attempt or who are persistently expressing suicidal intent
- Participants with implanted devices such as a pacemaker, cochlear implant, or neurostimulator.
- Participants with abnormal ear anatomy or ear infections
- Participants diagnosed with renal or hepatic failure
- Participants who are currently undergoing chemotherapy (Exception: Participation may be allowed if the investigator determines that participation poses no medical safety concerns for the participant)
- Participants who are currently engaged in high-risk occupations (e.g., transportation workers, crane operators, heavy machinery operators, individuals working with sharp objects, or those requiring a high level of...
- Participants with implanted metal or electronic devices in the head or neck area, including deep brain stimulators or pacemakers, as specified in the product precautions and contraindications (dental implants are exempt)
- Participants with cognitive impairment due to neurodevelopmental disorders (e.g., intellectual disability, developmental disorders, autism spectrum disorder) or neurodegenerative disorders (e.g., Alzheimer's disease...
- Participants who are pregnant or breastfeeding
- Female participants of childbearing potential who do not agree to abstain from sexual intercourse or to use medically accepted contraception\ during the study period. \ Medically accepted methods of contraception...
- Participants who are currently participating in another clinical trial or who have participated in another clinical trial within 30 days prior to screening
- Participants who, in the opinion of the investigator, are deemed inappropriate for participation due to ethical concerns or potential impacts on study outcomes
The study team makes the final eligibility decision.
Where it's taking place
- Daegu, Daegu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daegu, Daegu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.